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Software Validation Quality Consultant

Hamilton, NJ 08619

Posted: 06/05/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 607734 Is job remote?: No Country: United States

Job Description


Job Description:

The Software Validation Quality Consultant will work closely with the clinical quality assurance systems lead to deliver on internal validation efforts and audits of client's vendors and computerized systems.

Essential Functions:
• Participate in computer system and vendor audits for review of their Quality Management System, SDLC, including validation, and data integrity controls.
• Review CAPA and verification of CAPAs of system and vendor audits.
• QA approver for internal validation efforts.
• Act as liaison to the business for guidance and consultancy on software validation.
• Support health authority audits/inspections for inspection readiness.

Requirements:
• Bachelor’s degree in associated functional disciplines including IT, Data Sciences and others.
• Software development familiarity with both Agile and Waterfall methodology.
• Minimum 3-5 years' experience in Pharmaceutical industry or similar.
• Minimum 1-3 years' experience Vendor / Computerized System Validation (CSV) Auditing experience
• Knowledge of regulations governing software validation and development.
• Knowledge of GCP/GMP is preferred.
• Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently.
• Ability to Travel.
• Location: Nutley or hybrid.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Hamilton, NJ

Discover exciting job opportunities in the vibrant area surrounding Hamilton, New Jersey! Nestled in the heart of Mercer County, this charming town offers an ideal blend of suburban tranquility and urban energy. With its close proximity to Princeton University, renowned art galleries like Grounds For Sculpture, and bustling theaters like the George Street Playhouse, Hamilton is brimming with cultural attractions. Not to mention, food enthusiasts can indulge in the region's diverse cuisine scene, from classic diners to trendy bistros. Explore career growth in this thriving community, home to professional sports teams like the Trenton Thunder and scenic parks like Veterans Park. Embrace the enchanting charm of Hamilton, NJ, as you embark on a fulfilling career journey in this inviting locale. Start your job search today and unlock endless possibilities in this dynamic region!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.